Date of Visit/Assessment
Status T-SMBP
Eligibility Question
Eligibility Determination
boolean
Inclusion
text
Exclusion Criteria
text
Baseline Failure
Trial Screen Failure, Baseline
boolean
Trial Screen Failure, Baseline, Date in time
date
Trial Screen Failure, Baseline, Reason and justification
text
Trial Screen Failure, Baseline, Reason and justification
text
Trial Screen Failure, Baseline, Clinical Study Case, Investigator Signature
boolean
Pharmacogenetic (PGx) Research Withdrawal of Consent
Pharmacogenetic Test, Informed Consent, Withdraw
boolean
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
date
Pharmacogenetic Test, Blood specimen, Destruction, Request
boolean
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
text
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
text
Investigator Signature
Clinical Study Case, Investigator Signature
boolean
Clinical Study Case, Investigator Signature
boolean
Vital Signs
Systolic Pressure
integer
Diastolic blood pressure
integer
Systolic Pressure
integer
Diastolic blood pressure
integer
Systolic Pressure
integer
Diastolic blood pressure
integer
Heart rate
integer
Systolic Pressure, Low, Average
integer
Diastolic blood pressure, Low, Average
integer
Systolic Pressure, Screening procedure, Low, Average
integer
Diastolic blood pressure, Screening procedure, Low, Average
integer
IHS Headache Classification
Headache, Classification, aura; migraine without aura
boolean
Headache, Classification, Migraine with Aura
boolean
Migraine History
Migraine Disorders, Frequencies
integer
Migraine Disorders, Duration
text
Migraine Disorders, Age of Onset
integer
Migraine Disorders, Recurrence
boolean
Migraine Disorders, Headache, Frequencies
integer
Migraine Disorders, Headache, Frequencies
integer
Medical Conditions
Blood and lymphatic system disorders
text
Heart Diseases
text
Ear and labyrinth disorders
text
Endocrine System Diseases
text
Disorder of eye
text
Gastrointestinal Diseases
text
Hepatobiliary disease
text
Immune System and Related Disorders
text
Metabolism and nutrition disorders
text
Musculoskeletal and connective tissue disorders
text
Neoplastic disease
text
Nervous system disorder
text
Mental disorders
text
Urologic Diseases
text
Reproductive System and Breast Disorder Class
text
Respiratory, thoracic and mediastinal disorders
text
Dermatologic disorders
text
Vascular Diseases
text
Communicable Diseases, Infestation
text
Congenital, familial and genetic disorders
text
Cardiac Conditions
Heart Diseases, Sequence Number
integer
Heart Diseases
text
Heart Diseases, Reported Term
text
Heart Diseases, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
text
Heart Diseases, MedDRA Low Level Term Code
text
Heart Diseases, Code, Failed
text
Endocrine Disorders
Other [insert study specific classification] Conditions
Other diseases or conditions, Sequence Number
integer
Other diseases or conditions
text
Other diseases or conditions, Reported Term
text
Other diseases or conditions, Medical Dictionary for Regulatory Activities Terminology (MedDRA), Synonym
text
Other diseases or conditions, MedDRA Low Level Term Code
text
Other diseases or conditions, Code, Failed
text
Other diseases or conditions, Status
text
Baseline Risk Factors for CV Events
Hyperlipidemia
text
Diabetes Mellitus
boolean
Premature coronary artery disease
boolean
Tobacco use
boolean
Obesity
boolean
Physical Inactivity
boolean
Chronic disease; inflammatory
boolean
Elevated C-reactive protein level
text
Previous Treatment for Migraine
Migraine Disorders, Prior Therapy, Triptans
text
Migraine Disorders, Prior Therapy, Anti-Inflammatory Agents, Non-Steroidal
text
Migraine Disorders, Prior Therapy, Ergotamines
text
Migraine Disorders, Prior Therapy, Narcotics, Prescription document
text
Migraine Disorders, Prior Therapy, Analgesics
text
Migraine Disorders, Prior Therapy, Analgesics, OTC
text
Migraine Disorders, Prior Therapy, Aspirin / butalbital
text
Migraine Disorders, Prior Therapy, Tricyclic Antidepressive Agents
text
Migraine Disorders, Prior Therapy, Anticonvulsants
text
Migraine Disorders, Prior Therapy, Selective Serotonin Reuptake Inhibitors
text
Migraine Disorders, Prior Therapy, Adrenergic beta-Antagonists
text
Migraine Disorders, Prior Therapy, Calcium Channel Blockers
text
Migraine Disorders, Prior Therapy, Drugs used in migraine prophylaxis
text
Migraine Disorders, Prior Therapy, Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)
text
Migraine Disorders, Prior Therapy, Categories, Other
boolean
Migraine Disorders, Prior Therapy, Other
text
Migraine Disorders, Prior Therapy
text
Randomisation Number
Randomization
boolean
Randomization, Numbers
integer
Randomization, Date in time
date